Drug recall D-0287-2019
Product
Quetiapine Tablets USP 400 mg, 100 tablet bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India. Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 --- NDC 67877-248-01, UPC code: 3 67877-248-01 1
Reason for recall
Presence of Foreign Substance; metal shard found in tablet
Lots and codes
Lot 7143908, exp Nov 2020
Recall details
- Recalling firm
- Ascend Laboratories LLC, Parsippany, NJ
- Quantity
- N/A
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- November 14, 2018
- Terminated
- March 30, 2020
Related products
- Quetiapine – drug information
- NDC 67877-250 Quetiapine · Quetiapine Fumarate 100 mg/1 · Ascend Laboratories, LLC
- NDC 67877-247 Quetiapine · Quetiapine Fumarate 300 mg/1 · Ascend Laboratories, LLC
- NDC 67877-245 Quetiapine · Quetiapine Fumarate 150 mg/1 · Ascend Laboratories, LLC
- NDC 67877-242 Quetiapine · Quetiapine Fumarate 25 mg/1 · Ascend Laboratories, LLC
- NDC 67877-248 Quetiapine · Quetiapine Fumarate 400 mg/1 · Ascend Laboratories, LLC
- NDC 67877-249 Quetiapine · Quetiapine Fumarate 50 mg/1 · Ascend Laboratories, LLC
- NDC 67877-246 Quetiapine · Quetiapine Fumarate 200 mg/1 · Ascend Laboratories, LLC